Sr. Manufacturing Electrical Engineer

MiniMed•Los Angeles, CA

6d•$120,000 - $130,000•Hybrid

About The Position

This role focuses on designing, developing, validating, and documenting manufacturing processes at a Contract Manufacturer's site to ensure efficient PCBA production compliant with medical device standards. The engineer will provide engineering guidance and project support for product, process, tooling, and equipment design, development, and optimization. Key responsibilities include working with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and ISO 14971, demonstrating understanding of continuous glucose monitors and insulin pumps, and adhering to IPC Standards. The position involves managing PCB assembly line processes, leveraging DOE and DFMA, developing IQ/OQ/PQ/Gage R&R/TMV, and utilizing Six Sigma methodologies for NCMR and CAPA. The role requires proficiency with document control software (Agile, Trackwise, SAP) and manufacturing tools (Minitab) to ensure GMP and GDP compliance. The position is eligible for telecommuting with a requirement for physical presence at the Northridge, CA worksite 3-4 days a week.

Requirements

Master’s degree in Electrical, manufacturing or biomedical engineering, or a directly related engineering field.
Two (2) years experience in medical devices.
Development and optimization of products, processes, tooling and equipment.
FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971.
IPC Standards including IPC-6012, IPC-A-600, J-STD-001 and IPC-A-610.
PCB assembly line processes and operations.
DOE (Design of Experiments) and Design for Manufacturing and assembly (DFMA).
Development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV).
Six sigma, NCMR (Non-conforming Material Report) and CAPA (Corrective and Preventative Action).
Document control and manufacturing tool software including as Windchill, Agile, Trackwise, SAP and Minitab.

Responsibilities

Design, develop, validate, and document manufacturing processes at Contract Manufacturer’s site for efficient PCBA production in compliance with medical devices standards.
Provide engineering guidance and project support for the design, development, and optimization of products, processes, tooling, and equipment.
Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971.
Demonstrate understanding of design and manufacturing of continuous glucose monitors and insulin pumps.
Adhere to various IPC Standards including IPC-6012, IPC-A-600, J-STD-001 and IPC-A-610.
Manage PCB assembly line processes and operations.
Leverage DOE (Design of Experiments) and Design for Manufacturing and assembly (DFMA).
Develop Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV).
Utilize Six Sigma methodologies for NCMR (Non-conforming Material Report) and CAPA (Corrective and Preventative Action).
Leverage document control software including Agile, Trackwise and SAP for Navigating the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP).
Use manufacturing tools like Minitab to predict efficiency and deficiencies that were overlooked during the process.